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Elocon vs Fluticasone in Localized Psoriasis (P03197)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00763529
First received: September 29, 2008
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.


Condition Intervention Phase
Psoriasis
Drug: Mometasone
Drug: Fluticasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Elocon vs Fluticasone in Localized Psoriasis

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 4. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 8. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Mometasone
Mometasone furoate cream 0.1% applied once daily
Other Names:
  • Elocon
  • SCH 32088
Active Comparator: Arm 2 Drug: Fluticasone
Fluticasone propionate cream 0.05% applied twice daily
Other Name: Cutivate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=18 years of age
  • Written informed consent
  • Having localized psoriasis (not more than 5-6 patches)
  • Total size of all patches should be below 8" x 8"
  • Each patient should exhibit any of the following 4 signs of dermatoses:

    • erythema
    • palpability
    • scaling
    • itching (pruritus)

Each of the above signs would be grades according to the following scale:

0 = none

  1. = slight
  2. = moderate
  3. = severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)

Exclusion Criteria:

  • Pregnancy or lactation
  • Hypersensitivity to any of the components of the test medication
  • Signs of atrophy in the target area
  • Lesions on palms, soles, and scalp
  • Individuals who may require medications that might affect the natural course of the disease
  • Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
  • Concomitant tuberculosis/viral infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00763529     History of Changes
Other Study ID Numbers: P03197
Study First Received: September 29, 2008
Last Updated: October 14, 2008
Health Authority: India: NIL

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014